IMAP assessments—public comment

Update

Our responses to public comments from Tranche 21 and some earlier tranches are now available - see table below.

Summary of amendments made to IMAP assessments

Public comments have been received for IMAP assessment reports published for each tranche. All comments have been considered by NICNAS and, where appropriate, assessment reports have been amended as part of an ongoing process of refinement and improvement of IMAP outputs.

An overview of comments made regarding specific chemicals and NICNAS's response is provided in the following table. The table also provides information on updates made to IMAP assessments subsequent to their publication. Revised reports can be viewed by opening the links on the CAS Registry number or group assessment names below.

NICNAS is considering additional information provided for some chemicals published in previous Tranches (refer to assessment summary tables).

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section for the chemical 1H,3H,5H-Oxazolo[3,4-c]oxazole-7a(7H)-methanol (CAS number 6542-37-6).

No public comments were provided. Factual and/or editorial correction.

Assessment report has been amended to remove reference to Canada in the Public Risk Characterisation and Regulatory control (Public Health) sections, as Canada does not have restrictions on this chemical. In addition, Regulatory control (Public Health) section was amended to remove specific recommendation to Schedule 5 of the Standard for the Uniform Scheduling of Medicines and Poisons, in line with other scheduled hair dye chemicals.

Assessment report has been amended to include additional use information in the ‘Import, Manufacture and Use’ section for chemicals geranyl acetate, geraniol formate and nerol acetate (CAS numbers 105-87-3, 105-86-2, and 141-12-8, respectively).

Additional data was considered and the assessment report has been amended in the Public Risk Characterisation section to include an additional reference. The conclusion of the original assessment report remains unchanged.

Based on the use information provided, no changes to the reports were considered necessary. Should more detailed use information become available NICNAS will consider whether amendments to the reports are required.

Grouping rationale: the report currently acknowledges that the toxicity of perfluoroalkyl heptanoic acid (PFHpA) will be intermediate to PFHxA and perfluorooctanoic acid (PFOA) and ‘Based on toxicokinetic data, it is anticipated that long-term effects would occur at higher doses for PFHpA and its salt, compared with PFOA. However, a separate no-observed adverse effect level (NOAEL) cannot be established’.

NICNAS has considered the use of the analogue 7-H-dodecafluoroheptanoic acid (7-H-PFHpA; CAS No 1546-95-8) for assessing the toxicity of PFHpA. Overall, NICNAS has decided that it is not appropriate to include information in the report on the analogue, 7-H-PFHpA.

The information provided was sufficient to amend the use and/or volume information upon which the risk characterisation was based. Therefore the assessment report has been amended to include the information. This resulted in an amendment to the Public Health recommendation.

Grouping Rationale: editorial amendments made to highlight the PBT nature of PFOA and international concern about these chemicals due to their PBT properties.

Categorisation of Environment Hazard: no change to the report. provided explanation that supporting information for the categorisation of PFOA as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Environmental Effects: no change to the report. Provided explanation that supporting information for the categorisation of PFOA as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Grouping Rationale: editorial amendments made to highlight the PBT nature of PFOA and international concern about these chemicals due to their PBT properties.

Categorisation of Environment Hazard: no change to the report. Provided explanation that supporting information for the categorisation of PFOA as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Environmental Effects: no change to the report. Provided explanation that supporting information for the categorisation of PFOA as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Health Hazard Information: an editorial amendment to the report has been made to clarify the occurrence of benign tumours in experimental animals exposed to PFOS rather than malignant neoplasms.

Public Risk Characterisation: an editorial amendment to the report has been made to highlight that the PFOS levels found in human populations were many orders of magnitude lower than those that caused developmental effects in experimental rats.

Environmental Effects: no change to the report. Provided explanation that supporting information for the categorisation of PFOS as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Risk Characterisation: editorial amendments made to highlight the PBT nature of PFOS and related chemicals and international concern about these chemicals due to their PBT properties.

Regulatory Controls, Work Health and Safety: editorial amendment to the section to indicate that in the absence of toxicological data on the individual chemicals, classification for the chemicals in this group was based on PFOS.

Health hazard Information: editorial amendment to highlight the use of toxicity data for direct precursors of PFBS and PFOS to estimate the direct irritation potential of the chemicals.

Toxicokinetics: an editorial amendment has been made to the report, as follows: ‘Once absorbed, PFOS is eliminated from the human body very slowly. The mean elimination half-life of PFOS in humans was estimated to be to be 5.4 years (3.9–6.9 years) based on the serum'.

Toxicokinetics: amendments to references cited in the report.

Toxicokinetics: editorial amendments made to clarify the issue on temporal trend of PFOS in human milk.

Carcinogenicity: an editorial amendment to the report has been made to clarify the occurrence of benign tumours in experimental animals exposed to PFOS rather than malignant neoplasms.

Reproductive and Developmental Toxicity: new references added.

Regulatory Controls, Work Health and Safety: editorial amendment to the section to indicate that in the absence of toxicological data on the individual chemicals, classification for the chemicals in this group was based on PFOS.

Repeat Dose Toxicity: an editorial amendment to the report has been made so it is clear that there were no significant effects on serum thyrotropin, thyroid stimulating hormone or the mean thyroid follicular epithelial cell heights of rats treated with ammonium perfluorobutyrate (NH(4)(+)PFBA).

Grouping rationale: no change to the report. Provided explanation that in accordance with NICNAS policy for the assessment of perfluorinated chemicals under IMAP, 6:2 FTOH and other precursors which degrade to PFHxA are not considered direct precursors.

Environmental Fate: no change to the report. Provided explanation that the current text under “Dissolution, Speciation and Partitioning” heading states that volatilisation from water is possible but unlikely.

Environmental Fate: no change to the report. Provided explanation that, for the purposes of assessing perfluorinated chemicals on the AICS, NICNAS divided chemicals into direct precursors (chemicals such as salts and anhydrides which rapidly hydrolyse and/or dissociate to form the acid or sulfonate) and indirect precursors (those that degrade by other mechanisms).

Grouping rationale section: the information provided on the benzene content of some of the chemicals (CAS numbers. 64741-92-0, 64742-48-9, 64742-82-1 and 68526-55-6) was relevant for the critical health effects upon which the hazard and risk characterisation were based. Therefore, the assessment report has been amended to exclude these chemicals from the group assessment.

Respiratory irritation: Information provided was relevant. An amendment to the report was made.

Repeat dose toxicity (inhalation): information provided was relevant. An amendment to the report was made.

Reproductive and developmental toxicity: a small section of the report was replaced with relevant epidemiological information provided.

Hazard classification: based on the weight of evidence, no change to the recommended classifications for reproductive and developmental toxicity were made. These classifications were not new recommendations made by NICNAS (classifications were existing on the Hazardous System Information System (HSIS)). The recommended classifications are aligned with those of the European Union, which has extensively considered these hazards through the European Chemicals Agency.

The assessment report was republished for public comment with an additional chemical in tranche nineteen.

Update: assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.

Respiratory irritation: information provided was relevant. An amendment to the report was made.

Eye irritation: information provided was relevant. An amendment to the report was made.

Reproductive and developmental toxicity: a small section of the report was replaced with relevant epidemiological information provided.

Hazard classification: based on the weight of evidence, no change to the recommended classifications for reproductive and developmental toxicity were made. These classifications were not new recommendations made by NICNAS (classifications were existing on the Hazardous System Information System (HSIS)). The recommended classifications are aligned with those of the European Union, which has extensively considered these hazards through the European Chemicals Agency.

The assessment report was republished for public comment with additional chemicals in tranche nineteen.

Update: assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section

Chemical identities and structures: information provided was relevant. Amendments have been made to chemical names and structures.

Eye irritation: information provided was relevant. Chemical identity information has been updated in two studies.

Repeat dose toxicity (inhalation): information provided was relevant and prompted the inclusion of a recently published study in the report.

Reproductive and developmental toxicity: Information provided was relevant. Details of one section have been updated and an additional study has been included in the report.

Hazard classification: based on the weight of evidence, no change to the recommended classifications for reproductive and developmental toxicity were made. The recommended classifications are aligned with those of the European Union, which has extensively considered these hazards through the European Chemicals Agency.

Update: assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.

Repeat dose toxicity (inhalation) section: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation are now based. Therefore, the assessment report has been amended and the recommendation has been changed accordingly to indicate that ‘The chemical caused serious damage to the lungs in animal studies following repeated inhalation exposure to low levels. The relevance of these effects to humans will be evaluated as a part of the Tier III assessment’ (refer to pages 10, 14 and 15 of the assessment for detailed amendments).

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Reproductive toxicity section: added reference to toxicokinetics oral section to support the assertion that cobalt oxide and cobalt sulfate heptahydrate have similar bioavailability by oral exposure.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Repeated dose toxicity & Reproductive and developmental toxicity sections: revised based on new data provided. In a new study no adverse effects resulting in classification was observed for either repeated dose toxicity or reproductive/developmental toxicity. Hazard classification revised based on new data provided.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Repeated dose toxicity (Inhalation) and Carcinogenicity sections: additional text added to support the read across from soluble cobalt compounds.

The information provided for DINPs and B79P was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended and the recommendation has been changed to read that 'Should the new information become available, a Tier III assessment of hazard properties of DINPs, B79P and related compounds and subsequent effects on male offspring development be conducted to ascertain an appropriate GHS/HSIS classification'

The exposure information for B79P was relevant; therefore the assessment report has been amended to include the information

Correction in Restriction - International section: correction of the first dot point. Now reads: ‘synthetic organic polymers, as listed in the European Commission Regulation (EU) No 835/2012, > 0.01 % by weight of the plastic material’.

Additional information to the Toxicokinetics section: relevant bioaccessibility information and an inhalation study were provided. These have been added to the report.

Additional information to the Repeat dose toxicity - Inhalation section: relevant complementary data from cadmium telluride (CdTe) were provided. This data has been added to the report.

The assessment report was republished for public comment with an additional chemical in tranche nine. Following this additional data (health effect information/weight of evidence) was provided.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Acute inhalation section: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information.

Skin irritation section: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information.

NICNAS Recommendations: the additional information resulted in an amendment to the recommendation (Work Health & Safety).

Whilst classification for skin irritation and acute toxicity is still recommended. The recommendation now states 'The current HSIS classification for carcinogenicity of these chemicals indicates notes L and H. Based on this assessment, all of the classifications provided below should be subject to note L. Therefore, note L should be slightly modified as follows:

Note L: The classifications need not apply if it can be shown that the substance contains less than 3% DMSO extract as measured by the IP346 assay. This note only applies to certain complex oil-derived substances in Annex I.

Repeated dose inhalation section: re-wording and further clarification of the no observed adverse effect concentration (NOAEC) with respect to the two-year National Toxicology program (NTP) study conducted in rats.

Reproductive & developmental toxicity - Observations in humans: citation for Vaktskjold et al, 2004 added and editorial changes made to the last paragraph to provide clarity on specific reproductive outcomes assessed in the cited study.

Risk characterisation - Occupational risk characterisation: clarification provided to specify that the exposure standards specified in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i.

Acute toxicity - Inhalation: information received during the public comments period has advised NICNAS that an acute toxicity - inhalation study is currently underway. Therefore, the recommendation to change the classification for acute toxicity (inhalation) has been reverted to its initial classification on the Hazardous System Information System (HSIS). The existing classification will be reviewed once results of the study become available.

Risk characterisation - Occupational risk characterisation: clarification provided to specify that the exposure standards specified in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i. The GHS classification for developmental toxicity has now been specified as H360D. A typographical error has now been corrected to identify the acute oral toxicity of the chemicals in this group as "Cat. 4 (H302)".

Repeated dose inhalation section: re-wording and further clarification of the No Observed Adverse Effect Concentration (NOAEC) with respect to the two-year National Toxicology program (NTP) study conducted in rats.

Reproductive & developmental toxicity - observations in humans: citation for Vaktskjold et al., 2004 added and editorial changes made to the last paragraph to provide clarity on specific reproductive outcomes assessed in the cited study.

Risk characterisation - occupational risk characterisation: clarification provided specified that the exposure standards in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i.

Risk characterisation - occupational risk characterisation: clarification provided specified that the exposure standards in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i. The GHS classification for developmental toxicity has now been specified as H360D. A typographical error has now been corrected under the GHS classification to correctly read "harmful if inhaled Cat.4 (H332)".

The exposure information provided was considered relevant to the risk characterisation; therefore the assessment report has been amended to include the information.

Editorial amendments were made to the report. The regulatory impact of risk management on (industry and/or regulatory agencies) should be taken into consideration by the regulatory agencies when determining what risk management action is required.

The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based. Therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).

2015: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based. The assessment report has been amended and the recommendation has been changed accordingly to indicate that 'The chemicals are recommended for Tier III assessment to determine the concentration of TPP that would lead to classification of these chemicals for reproductive toxicity'.

2013: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based. Therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).

No public comments were provided, however, NICNAS identified additional health effect information.

The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).

No public comments were provided, however, NICNAS identified additional health effect information.

Additional chemicals identified for inclusion in the group assessment were published in tranche six.

The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).

Assessment report has been amended to include additional information relevant to carcinogenicity and a recommendation for NICNAS to evaluate exposure based on cosmetic use at Tier III. These changes are reflected in the NICNAS Recommendation and Regulatory Control: Public Health sections.

No public comments were provided, however, NICNAS identified additional health effect information.

Additional chemicals identified for inclusion in the group assessment were published in tranche six.

The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).

The information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information.

The exposure information provided was already considered in the original assessment, resulting in no change to the report's findings.